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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).
This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, Then Alfuzosin | Placebo Comparator | Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks. |
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| Alfuzosin, Then Placebo | Experimental | Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Alfuzosin-matched One tablet once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Erectile Function Domain of the International Index of Erectile Function | The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction. | Baseline and 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in American Urological Association (AUA) Symptom Index | The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald F Tutrone, MD | Chesapeake Urology Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesapeake Urology Research Associates | Baltimore | Maryland | 21204 | United States | ||
| Chesapeake Urology Research Associates |
Prior or current therapies of Alpha Blocker or PDE 5 inhibitor 2 weeks prior to randomization or investigational agents 30 days prior to randomization excluded them. 11 participants screen failed.
Private Urology Practice, recruited patients from June 2009 through May 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Alfuzosin | Placebo: one tablet daily first, then 10 mg Alfuzosin daily |
| FG001 | Alfuzosin, Then Placebo | Alfuzosin: 10 mg once daily first, then one Placebo tablet daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Alfuzosin | Drug | 10 mg once daily |
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| Baseline and 12 Weeks |
| Change in Total International Index of Erectile Function (IIEF) Score | The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction). | Baseline and 12 Weeks |
| Baltimore |
| Maryland |
| 21237 |
| United States |
| Chesapeake Urology Research Associates | Glen Burnie | Maryland | 21061 | United States |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, Then Alfuzosin | Placebo: one tablet daily first, then 10 mg Alfuzosin daily |
| BG001 | Alfuzosin, Then Placebo | Alfuzosin: 10 mg once daily first, then one Placebo tablet daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Erectile Function Domain of the International Index of Erectile Function | The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction. | The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed. | Posted | Mean | Standard Deviation | Change in EF Domain Score from Baseline | Baseline and 12 Weeks |
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| Secondary | Changes in American Urological Association (AUA) Symptom Index | The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35). | The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed. | Posted | Mean | Standard Deviation | Change in AUA Score From Baseline | Baseline and 12 Weeks |
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| Secondary | Change in Total International Index of Erectile Function (IIEF) Score | The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction). | The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed. | Posted | Mean | Standard Deviation | Change in Total IIEF Score from Baseline | Baseline and 12 Weeks |
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Every 12 weeks for each intervention.
Adverse Events (AEs) were assessed at each visit by interviewing the patient. The Investigator assessed each AE and the relationship to the drug. AEs were only recorded if they were not listed on the label of Alfuzosin as a potential side effect.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo, Then Alfuzosin | Placebo: one tablet daily first, then 10 mg Alfuzosin daily | 1 | 36 | 0 | 36 | ||
| EG001 | Alfuzosin, Then Placebo | Alfuzosin: 10 mg once daily first, then one Placebo tablet daily | 1 | 38 | 0 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment | The assesment in the hospital revealed unclear etiology and the subject was discharged with a treatment plan to continue with pre admission medications, activity and diet. The subject was discontinued from the trial via withdrawal of consent |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Patient was admitted to the hospital for Shortness of Breath, pleuritic right sided chest pain. Patient was discontinued from trial via Investigator discretion. |
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Data compiled in this study is unable to neither prove nor disprove the objectives set. Placebo effect and recall bias may affect results. Regular sexual interaction and prior exposure to Alfuzosin were not evaluated.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Tutrone, MD | Chesapeake Urology Research Associates | 443.471.5742 | hthomas@cua.md |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C047638 | alfuzosin |
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| >=65 years |
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| Male |
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